RESEARCH TRIANGLE PARK, N.C., Oct. 24 /PRNewswire/ -- Viron Therapeutics, Inc. signed an agreement with Diosynth Biotechnology for process development, scale-up, and clinical manufacturing for their lead product candidate.
Under the agreement, Diosynth Biotechnology will support the process improvement, process development and clinical product manufacturing for Viron's lead molecule VT-111.
"We are very pleased to be working with Viron," said Frank Tielens, President of Diosynth Biotechnology. "Our experience in technology transfer, in process development and in cGMP production and our regulatory history have certainly been noticed and appreciated by the industry." Tielens added "Because of these strengths, we have been rewarded with innovative customers such as Viron whose VT-111 product was recently identified as one the ten most promising cardiovascular drug candidates in development."
VT-111 is currently in Phase II clinical trials for the treatment of the inflammation associated with Acute Coronary Syndrome.
"We have entrusted Diosynth with the clinical manufacturing of our lead drug candidate, VT-111, as they have proven themselves to be world leaders in this area," stated Neil K. Warma, President and Chief Executive Officer of Viron. "The manufacturing process developed will ultimately support pivotal trials and the eventual market launch of VT-111, which is currently being tested in a multi-center Phase II clinical trial, and we are pleased to have such a strong partner in Diosynth," added Warma.
Diosynth Biotechnology is a division of Organon that supplies contract manufacturing services for the global biotechnology industry. The company has an 80-year heritage in biologics manufacturing and is a global leader in technology-driven process development and cGMP manufacturing of recombinant proteins, monoclonal antibodies and peptides. We help our customers succeed by developing scalable and robust processes and by driving products efficiently, rapidly and cost-effectively from preclinical development to market supply. Diosynth Biotechnology serves pharmaceutical and biopharmaceutical customers globally and operates FDA-, Health Canada- and EMEA-inspected cGMP manufacturing facilities in Research Triangle Park, NC USA, and Oss, the Netherlands. Diosynth Biotechnology is part of Akzo Nobel's human healthcare business unit Organon. The Akzo Nobel Safe Harbor Statement (below) applies to this press release. For more information: http://www.diosynthbiotechnology.com
About Viron Therapeutics Inc.
Viron Therapeutics Inc. is a clinical stage biopharmaceutical company focused upon the commercialization of novel anti-inflammatory therapeutics. The company is based upon the vision of the founding scientists, Grant McFadden, Ph.D. and Alexandra Lucas, M.D., who have extensive expertise in viral pathogenesis and interventional cardiology, respectively, and who have been instrumental in the development of the drug candidates for over a decade. Viron is focused on the development of therapeutics derived from viral proteins as a sustainable and unexploited source of novel drugs. Harnessing the evolutionary power of viruses that naturally produce potent anti- inflammatory proteins allows Viron to identify and develop powerful protein therapeutics that target the most effective pathways regulating the body's inflammatory responses to promote healing. More information is available at http://www.vironinc.com
Diosynth Safe Harbor Statement*
This press release may contain statements which address such key issues as the Akzo Nobel growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals. Such statements, including but not limited to the "Outlook", should be carefully considered and it should be understood that many factors could cause forecasted and actual results to differ from these statements. These factors include, but are not limited to, price fluctuations, currency fluctuations, developments in raw material and personnel costs, pensions, physical and environmental risks, legal issues, and legislative, fiscal, and other regulatory measures. These factors also include changes in regulations or interpretations related to the implementation and reporting under IFRS, decisions to apply a different option of presentation permitted by IFRS, and various other factors related to the implementation of IFRS, including the implementation of IAS 32 and 39 for financial instruments. Stated competitive positions are based on management estimates supported by information provided by specialized external agencies. For a more complete discussion of the risk factors affecting our business please refer to the Akzo Nobel Annual Report on Form 20-F filed with the United States Securities and Exchange Commission, a copy of which can be found on the Akzo Nobel website. * Pursuant to the U.S. Private Securities Litigation Reform Act 1995.